JP2009261945A - Flowable collagen material for dural closure - Google Patents
Flowable collagen material for dural closure Download PDFInfo
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- JP2009261945A JP2009261945A JP2009103842A JP2009103842A JP2009261945A JP 2009261945 A JP2009261945 A JP 2009261945A JP 2009103842 A JP2009103842 A JP 2009103842A JP 2009103842 A JP2009103842 A JP 2009103842A JP 2009261945 A JP2009261945 A JP 2009261945A
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- 239000000463 material Substances 0.000 title claims abstract description 99
- 102000008186 Collagen Human genes 0.000 title claims abstract description 67
- 108010035532 Collagen Proteins 0.000 title claims abstract description 67
- 229920001436 collagen Polymers 0.000 title claims abstract description 67
- 230000009969 flowable effect Effects 0.000 title claims abstract description 50
- 239000000843 powder Substances 0.000 claims abstract description 31
- 239000007788 liquid Substances 0.000 claims abstract description 12
- 238000000034 method Methods 0.000 claims description 24
- 241000283690 Bos taurus Species 0.000 claims description 10
- 239000002245 particle Substances 0.000 claims description 10
- 239000002504 physiological saline solution Substances 0.000 claims description 5
- 210000001951 dura mater Anatomy 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 3
- 230000001605 fetal effect Effects 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 210000000813 small intestine Anatomy 0.000 claims description 2
- 210000004876 tela submucosa Anatomy 0.000 claims description 2
- 238000002513 implantation Methods 0.000 abstract description 5
- 239000000565 sealant Substances 0.000 abstract description 5
- 239000000853 adhesive Substances 0.000 abstract description 4
- 230000001070 adhesive effect Effects 0.000 abstract description 4
- 230000004888 barrier function Effects 0.000 abstract description 4
- 239000008280 blood Substances 0.000 abstract description 2
- 210000004369 blood Anatomy 0.000 abstract description 2
- 230000000740 bleeding effect Effects 0.000 abstract 1
- 230000003020 moisturizing effect Effects 0.000 abstract 1
- 230000003014 reinforcing effect Effects 0.000 abstract 1
- 238000005728 strengthening Methods 0.000 abstract 1
- 210000001519 tissue Anatomy 0.000 description 8
- 210000002418 meninge Anatomy 0.000 description 6
- 230000006378 damage Effects 0.000 description 5
- 230000008439 repair process Effects 0.000 description 4
- 210000000278 spinal cord Anatomy 0.000 description 4
- 230000008961 swelling Effects 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 3
- 210000004556 brain Anatomy 0.000 description 3
- 238000004132 cross linking Methods 0.000 description 3
- 230000023597 hemostasis Effects 0.000 description 3
- 208000014674 injury Diseases 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 241001269524 Dura Species 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- 239000008273 gelatin Substances 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 239000003102 growth factor Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000003892 spreading Methods 0.000 description 2
- 230000007480 spreading Effects 0.000 description 2
- KZNICNPSHKQLFF-UHFFFAOYSA-N succinimide Chemical compound O=C1CCC(=O)N1 KZNICNPSHKQLFF-UHFFFAOYSA-N 0.000 description 2
- 201000002345 Brain compression Diseases 0.000 description 1
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 239000003443 antiviral agent Substances 0.000 description 1
- 210000000576 arachnoid Anatomy 0.000 description 1
- 230000001588 bifunctional effect Effects 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 210000005013 brain tissue Anatomy 0.000 description 1
- 150000001718 carbodiimides Chemical class 0.000 description 1
- 210000003169 central nervous system Anatomy 0.000 description 1
- 239000000512 collagen gel Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000003431 cross linking reagent Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000003623 enhancer Substances 0.000 description 1
- 239000003349 gelling agent Substances 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 229960003444 immunosuppressant agent Drugs 0.000 description 1
- 239000003018 immunosuppressive agent Substances 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- WSFSSNUMVMOOMR-NJFSPNSNSA-N methanone Chemical compound O=[14CH2] WSFSSNUMVMOOMR-NJFSPNSNSA-N 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
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- 210000005036 nerve Anatomy 0.000 description 1
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- 239000008213 purified water Substances 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 229960002317 succinimide Drugs 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000008467 tissue growth Effects 0.000 description 1
- 238000009281 ultraviolet germicidal irradiation Methods 0.000 description 1
- 239000011345 viscous material Substances 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/24—Collagen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Surgery (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
Description
〔分野〕
本出願は、接着性バリアとして、身体組織を修復、交換、補強、または強化するための、あるいは、保湿、止血、もしくは組織保護のために短期間の身体接触物として使用するための、流動可能なコラーゲン硬膜グラフト材料に関する。
[Field]
This application is flowable, as an adhesive barrier, to repair, replace, reinforce, or strengthen body tissue, or to use as a short-term body contact for moisturization, hemostasis, or tissue protection The present invention relates to a novel collagen dural graft material.
〔背景〕
ヒトの脳および脊髄は、髄膜(meningeal membranes)を含む髄膜システム(meningeal system)により保護され、保存され、かつ被われている。髄膜は、3つの重なった組織層、すなわち:硬膜(dura mater)(または硬膜(dura))の最外側層、くも膜の中間層、および軟膜の最内側層、の入り組んだネットワークから構成されている。最外側層は、強くて弾力性があり、耐水性である。最内側層は、脳および脊髄の表面全体に沿ってたどり、この表面全体に接触しており、脳および脊髄に助力を与えるように血管を運んでいる。中間層は、内側表面と外側表面との間の滑りシステム(gliding system)として働く。このネットワークへのあらゆる損傷が、中枢神経系に深刻な問題を引き起こす。
〔background〕
The human brain and spinal cord are protected, preserved and covered by a meningeal system including meningeal membranes. The meninges are composed of an intricate network of three overlapping tissue layers: the outermost layer of the dura mater (or dura), the middle layer of the arachnoid membrane, and the innermost layer of the buffy coat Has been. The outermost layer is strong, elastic and water resistant. The innermost layer follows along the entire surface of the brain and spinal cord, touches the entire surface, and carries blood vessels to assist the brain and spinal cord. The intermediate layer acts as a gliding system between the inner surface and the outer surface. Any damage to this network causes serious problems for the central nervous system.
損傷した髄膜を修復することは、硬膜代用品として知られている植え込み可能な、および/または吸収可能な構造物に主として焦点を合わせて来た。これらの硬膜代用品は、損傷した硬膜に接ぎ合わされ、損傷した組織を交換および/または再生するよう設計されている。合成の、および動物に基づく、多数の硬膜修復製品が、現在入手可能である。しかしながら、これらのほとんどは、典型的にはスポンジ、シート、不織マトリクス、もしくはこれらの組み合わせで入手可能である、縫合可能なグラフト、またはアンレー(縫合なし(sutureless))グラフトのいずれかに分類される。ある場合には、これらの製品は、適用するのが難しいことがあり、可撓性または成形性が限定されることもあり、それらの製品を損傷領域全体に適切に到達させることができないかも知れない。 Repairing damaged meninges has primarily focused on implantable and / or absorbable structures known as dural substitutes. These dura mater substitutes are designed to interface with damaged dura mater and replace and / or regenerate damaged tissue. A number of synthetic and animal based dural repair products are currently available. However, most of these are categorized as either stitchable grafts or onlay (sutureless) grafts, typically available in sponges, sheets, nonwoven matrices, or combinations thereof. The In some cases, these products may be difficult to apply and may be limited in flexibility or formability and may not allow them to properly reach the entire damaged area. Absent.
合成ゼラチンおよびポリマーの硬膜シーラントもまた開示されて来た。しかしながら、これらの合成シーラントには、ある問題もまた残っている。あるものは多孔質であるため、厳密な封鎖を作り出すことができない。それらはまた、弾性がない、および/または不溶性であるため、時間を浪費する適用につながる。さらにまた、多数が、処置に先立って調製されるのではなく、むしろ手術部位で水和されるか、または混合されなければならないので、適用および/または植え込みされるやいなや膨潤に供される。植え込み後の材料の膨潤は、例えばその膨潤が脳組織、神経根、または脊髄の圧迫を引き起こす場所では、患者にとって有害となり得る。 Synthetic gelatin and polymeric dural sealants have also been disclosed. However, certain problems also remain with these synthetic sealants. Some are porous and cannot create a tight seal. They are also inelastic and / or insoluble, leading to time consuming applications. Furthermore, many are subjected to swelling as soon as they are applied and / or implanted because they must be hydrated or mixed at the surgical site rather than being prepared prior to treatment. Swelling of the material after implantation can be detrimental to the patient, for example where the swelling causes compression of brain tissue, nerve roots, or spinal cord.
このように、従来の硬膜グラフトを適用するのが難しい領域または場所で使用するのに特に適応された硬膜グラフト材料が必要とされている。さらにまた、植え込み後の膨潤を最小限にするか、または排除するだけでなく、損傷を修復するために必要なインプラント材料の分量を減らす硬膜グラフト材料が必要とされている。最後に、従来の硬膜グラフト製品に比較して、嵌合性(mateability)、危険、および時間持続性の点から処置を単純化する硬膜グラフト材料が必要とされている。 Thus, there is a need for a dural graft material that is particularly adapted for use in areas or locations where conventional dural grafts are difficult to apply. Furthermore, there is a need for a dural graft material that not only minimizes or eliminates post-implantation swelling, but also reduces the amount of implant material required to repair the damage. Finally, there is a need for a dural graft material that simplifies treatment in terms of mateability, danger, and time persistence compared to conventional dural graft products.
〔概要〕
本発明は、例えば硬膜グラフトとして、有用で流動可能なコラーゲングラフト材料を提供する。これらのグラフト材料は、コラーゲン粉末と、関連する領域への適用のために流動可能な粘稠度を与えるのに有効な量の液体とを含む。コラーゲングラフト材料は、硬膜グラフトとして使用されるときには、コラーゲンシートまたは合成ゼラチンもしくはポリマーの硬膜シーラントといった典型的なより硬質の硬膜グラフトよりも、手術部位との優れた接触性と、より容易なアクセスとの両方を提供するように、十分に流動可能である。流動可能なグラフト材料は、鋳造可能および/または押し出し成形可能であり、また、その他の材料ではそれらが適切な可撓性または成形性を有していないために、ある部位に単純にアクセスすることができない領域における特別な適用性を有する。
〔Overview〕
The present invention provides a useful and flowable collagen graft material, for example as a dural graft. These graft materials include collagen powder and an amount of liquid effective to provide a flowable consistency for application to the relevant area. Collagen graft material, when used as a dural graft, has better contact with the surgical site and easier than typical harder dural grafts such as collagen sheets or synthetic gelatin or polymeric dural sealants It is sufficiently fluid to provide both secure access. Flowable graft materials are castable and / or extrudable, and other materials simply do not have the proper flexibility or formability so that they have simple access to a site. Has special applicability in areas where it cannot.
流動可能なコラーゲングラフト材料は、適用および植え込み後に膨潤する製品といったその他の材料(合成硬膜シーラント(止血製品))に関連する植え込み後の問題を減らす、および/または排除するための適用に使用されることもできる。 Flowable collagen graft materials are used in applications to reduce and / or eliminate post-implantation problems associated with other materials (synthetic dural sealants (hemostatic products)) such as products that swell after application and implantation. You can also.
他の側面において、本明細書中に記述される流動可能なコラーゲングラフト材料を利用して、損傷した硬膜を修復するための方法が提供される。ある一つの側面において、この方法は、コラーゲンおよび液体の混合物を含む流動可能な硬膜グラフト材料を所望の部位に適用することと、この部位の弯曲に硬膜グラフト材料を適合させることとを含む。流動可能なグラフト材料は、シリンジからの噴出、および手で広げることを含めた、種々の技術により適用されることができる。 In another aspect, a method is provided for repairing a damaged dura utilizing the flowable collagen graft material described herein. In one aspect, the method includes applying a flowable dural graft material comprising a mixture of collagen and liquid to a desired site and adapting the dural graft material to the curvature of the site. . The flowable graft material can be applied by a variety of techniques, including ejection from a syringe and spreading by hand.
〔詳細な説明〕
ここで、本明細書に開示される装置および方法の構造、機能、製造、使用の原理の包括的理解を提供するために、ある例示的な実施形態を説明する。本明細書に詳細に記述され、かつ添付の図面に示された装置および方法が、非限定的な例示の実施形態であり、その対象範囲(scope)が、請求項によってのみ定義されることを、当業者は理解するであろう。ある一つの例示的な実施形態と関連して説明されるか、または記述された特徴は、他の実施形態の特徴と組み合わせられてもよい。このような改変および変更は、本出願の対象範囲内に含まれることが意図されている。
[Detailed explanation]
Certain exemplary embodiments are now described to provide a comprehensive understanding of the principles of structure, function, manufacture, and use of the devices and methods disclosed herein. It is to be understood that the devices and methods described in detail herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, the scope of which is defined only by the claims. Those skilled in the art will understand. Features described or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and changes are intended to be included within the scope of this application.
本発明のある一つの側面は、流動可能で流動化されたゲル状および/またはペースト状の形態(flowable, fluidized, gel-like and/or paste-like form)で分配されることができ、適用の間に、所望の場所に適合して適所にとどまるように成形されることができる硬膜グラフト材料を提供する。硬膜代用品もしくは接着性バリア、または、保湿、止血、もしくは組織保護のための短期間の身体接触物としての使用においては、流動可能な硬膜グラフト材料は、所望の身体組織に接触するように設けられてもよい。ひとたび所望の部位に植え込まれると、この材料がペーストのような粘稠度を有することから、流動可能なコラーゲン材料と身体組織との間の接触性が維持される。時間の経過とともに、通常は約3〜6ヶ月で、流動可能なコラーゲン材料は、完全に吸収されるであろう。 One aspect of the present invention can be distributed and applied in a flowable, fluidized, gel-like and / or paste-like form. In between, a dural graft material that can be shaped to fit in the desired location and remain in place is provided. In use as a dural substitute or adhesive barrier, or short-term body contact for moisturization, hemostasis, or tissue protection, the flowable dural graft material will contact the desired body tissue. May be provided. Once implanted at the desired site, the material has a paste-like consistency, thus maintaining contact between the flowable collagen material and body tissue. Over time, usually in about 3-6 months, the flowable collagen material will be fully absorbed.
本出願に従う流動可能なコラーゲン材料は、コラーゲン粉末および結果として得られる製品に流動可能な粘稠度を与えるのに有効な量の液体から形成されることができる。粘稠度においてゲルおよび/またはペーストのようである、この流動可能な製品は、以下に記述されるような多数の技術により所望の場所に適用されることができる。さらに、流動可能な材料であることから、本明細書中で記述される硬膜グラフト材料は、この硬膜グラフト材料が植え込まれる解剖学的部位の幾何形状(geometery)、例えば硬膜損傷部位の弯曲に、十分に適合することができるように鋳造されることができる。 The flowable collagen material according to the present application can be formed from an amount of liquid effective to provide flowable consistency to the collagen powder and the resulting product. This flowable product, like gels and / or pastes in consistency, can be applied to the desired location by a number of techniques as described below. In addition, because it is a flowable material, the dural graft material described herein is an anatomical geometry, such as a dural injury site, into which the dural graft material is implanted. Can be cast to fit well into
本明細書中で記述される流動可能な硬膜代用品のためのコラーゲン源は、当業者に既知の種々の源から得ることができる。例えば、そのようなコラーゲン源としては、ウシ由来コラーゲン(bovine collagen)(例えばタイプ1ウシ由来コラーゲン)、ならびに、ブタ由来コラーゲン(porcine collagen)、ブタ小腸粘膜下組織、およびウシ胎児皮膚を含むことができる。 Collagen sources for the flowable dural substitutes described herein can be obtained from a variety of sources known to those skilled in the art. For example, such collagen sources include bovine collagen (eg, type 1 bovine collagen), and porcine collagen, porcine small intestine submucosa, and fetal bovine skin. it can.
全般的に、コラーゲン材料は粉末化された形態にあるが、この粉末は、コラーゲン材料のシートから得ることができ、このシートは、所望の粒度分布を有する粉末へと粉砕される。例示的なコラーゲン材料は、このコラーゲンを粉末形態に粉砕する前または後のいずれでもよいが、流動可能な材料を形成するために液体と組み合わせる前に、架橋されることができる。その代わりに、流動可能なコラーゲングラフト材料は、蒸気架橋(vapor crosslinking)または溶液架橋(solution crosslinking)を含めた種々の既知の技術により架橋されてもよい。例示的な架橋剤としては、ホルムアルデヒド、グルタルアルデヒド、カルボジイミド、および二官能性スクシンイミドを含む。流動可能なコラーゲングラフト材料はまた、デヒドロサーマル架橋(dehydrothermal crosslinking)またはUV照射により架橋されてもよい。 Generally, the collagen material is in a powdered form, but this powder can be obtained from a sheet of collagen material, which is ground into a powder having the desired particle size distribution. Exemplary collagen materials can be either before or after the collagen is ground into a powder form, but can be cross-linked prior to combining with a liquid to form a flowable material. Instead, the flowable collagen graft material may be crosslinked by various known techniques including vapor crosslinking or solution crosslinking. Exemplary cross-linking agents include formaldehyde, glutaraldehyde, carbodiimide, and bifunctional succinimide. The flowable collagen graft material may also be crosslinked by dehydrothermal crosslinking or UV irradiation.
コラーゲン材料の粒径は、材料の所望の使用、および流動可能な材料の所望の特性のような因子に依存して変化し得る。ある一つの実施形態において、流動可能な硬膜グラフト材料のコラーゲン粉末の粒径は、約0.1〜10,000ミクロンの範囲内にある。他の実施形態において、コラーゲン粉末は、約10〜1,000ミクロンの範囲内にある粒径を有する。さらに他の実施形態において、コラーゲン粉末は、約50〜800ミクロンの範囲内にある粒径を有する。さらなる実施形態において、コラーゲン粉末は、約100〜400ミクロンの範囲内にある粒径を有する。 The particle size of the collagen material can vary depending on factors such as the desired use of the material and the desired properties of the flowable material. In one embodiment, the flowable dural graft material collagen powder has a particle size in the range of about 0.1 to 10,000 microns. In other embodiments, the collagen powder has a particle size in the range of about 10 to 1,000 microns. In yet other embodiments, the collagen powder has a particle size in the range of about 50-800 microns. In further embodiments, the collagen powder has a particle size in the range of about 100 to 400 microns.
当業者は、種々の生体適合性の液体が、流動可能なグラフト材料を形成するためにコラーゲン材料に混合され得ることを認識するであろう。例示的な液体としては、水(例えば、精製水)、生理食塩水、血液、血漿、コラーゲンゲル、および当技術分野で一般に使用されるその他のあらゆる生体適合性の溶媒を含む。 One skilled in the art will recognize that a variety of biocompatible liquids can be mixed with the collagen material to form a flowable graft material. Exemplary liquids include water (eg, purified water), saline, blood, plasma, collagen gel, and any other biocompatible solvent commonly used in the art.
流動可能な硬膜グラフト材料を形成するために使用されるコラーゲンおよび液体の相対量は、所望の適用および特性に依存して変化し得る。当業者は、所望の使用および適用技術のために好適な流動可能なグラフト材料に到達するためのこれらの成分の適切な比率を容易に決定することができる。例えば、例えば従来のシリンジを介して注入可能にされるべき流動可能な材料は、その他の技術(例えば、人の手による適用)によって適用されるべき流動可能な硬膜グラフト材料よりも、概ね、粘稠性がより低くされるべきである。当業者は、従来のシリンジが、遠位端部に標準的なルアーロックを有することを認識するであろう。しかしながら、異なるサイズの開口部を備えた特注シリンジ(custom syringe)は、より濃厚で、より粘稠性のある材料が送達され得るように、設計されることができる。これらの条件(qualifications)に応じて、コラーゲン粉末成分は、概ね、約25%(wt/wt%)の量で存在することができる。他の実施形態において、コラーゲン粉末成分は、約20%(wt/wt%)の量で存在することができる。さらなる実施形態において、コラーゲン粉末成分は、約11%(wt/wt%)の量で存在することができる。さらに他の実施形態においては、コラーゲン粉末成分は、約6%(wt/wt%)の量で存在することができる。 The relative amounts of collagen and liquid used to form the flowable dural graft material can vary depending on the desired application and properties. One skilled in the art can readily determine the appropriate ratio of these components to reach a flowable graft material suitable for the desired use and application technique. For example, a flowable material to be made injectable, for example, via a conventional syringe, is generally more than a flowable dural graft material to be applied by other techniques (eg, application by human hands), The consistency should be lower. One skilled in the art will recognize that conventional syringes have a standard luer lock at the distal end. However, custom syringes with different sized openings can be designed so that thicker and more viscous materials can be delivered. Depending on these qualifications, the collagen powder component can be generally present in an amount of about 25% (wt / wt%). In other embodiments, the collagen powder component can be present in an amount of about 20% (wt / wt%). In a further embodiment, the collagen powder component can be present in an amount of about 11% (wt / wt%). In yet other embodiments, the collagen powder component can be present in an amount of about 6% (wt / wt%).
当業者は、流動可能なグラフト材料に種々の添加物が取り込まれ得ることを認識するであろう。そのような添加物の例としては、有効量の、抗菌剤、生理活性化合物、成長因子、免疫抑制剤、浸透促進剤(permeation enhancers)、抗ウイルス剤、制癌剤、およびゲル化剤を含む。流動可能なグラフト材料はまた、有効量の髄膜組織の成長因子を含んでもよい。 Those skilled in the art will recognize that various additives can be incorporated into the flowable graft material. Examples of such additives include effective amounts of antibacterial agents, bioactive compounds, growth factors, immunosuppressants, permeation enhancers, antiviral agents, anticancer agents, and gelling agents. The flowable graft material may also include an effective amount of meningeal tissue growth factor.
本明細書中に記述されている流動可能なグラフト材料は、硬膜グラフトとして使用されることもできるし、あるいは、保湿、止血、および組織保護のための短期間の身体接触物のための接着性バリアとしての適用を含めた、種々のその他の適用において使用されることもできる。流動可能なグラフトおよびその使用方法は、硬膜グラフトと関連して主に記述されているが、当業者は、そのような材料の追加の使用および適用を理解するであろう。意図されている使用とは無関係に、流動可能なコラーゲン材料は、流動化されたペーストまたはゲル状態で送達され得ることもできる。材料を適用するための、ある一つの例示的な方法は、シリンジのような送達装置からの噴出によるものである。この材料は、所望のパターンでの送達装置からの噴出により適用されることもできるし、あるいは、その他の技術により(例えば、人の手によるか、または他の取り扱いツールにより)適用され、続いて所望のパターンに成形されることもできる。例えば、より濃厚なペーストについては、この材料は、コーキングガン(caulking gun)または類似のタイプのシステムを用いて、噴出されてもよい。 The flowable graft material described herein can be used as a dural graft or adhesive for short-term body contact for moisturization, hemostasis, and tissue protection It can also be used in a variety of other applications, including application as a sexual barrier. Although flowable grafts and methods of use thereof have been described primarily in connection with dural grafts, those skilled in the art will appreciate additional uses and applications of such materials. Regardless of the intended use, the flowable collagen material can also be delivered in a fluidized paste or gel state. One exemplary method for applying the material is by ejection from a delivery device such as a syringe. This material can be applied by ejection from the delivery device in the desired pattern, or it can be applied by other techniques (eg, by a human hand or by other handling tools) followed by It can also be formed into a desired pattern. For example, for thicker pastes, this material may be ejected using a caulking gun or similar type system.
ある一つの実施形態において、硬膜グラフト材料は、それが外科手術部位に適用される前に、調製される。しかしながら、この材料は、外科手術部位への適用と同時に調製されてもよい。 In one embodiment, the dural graft material is prepared before it is applied to the surgical site. However, this material may be prepared simultaneously with application to the surgical site.
流動可能なコラーゲングラフトのある一つの使用は、外科処置において、損傷した髄膜を修復または保護するための硬膜グラフト材料としての使用である。グラフト材料は、頭蓋の開口部を通して所望の適用技術により(例えば、送達装置からの噴出により)有効量の流動可能なコラーゲングラフトを適用することにより植え込まれることができ、関連する領域で髄膜に接触した状態で設けられる。有効量の流動可能なコラーゲン硬膜グラフト材料は、損傷していない髄膜の部分にわずかに重なり、そして接触するのに十分な分量を含んでもよい。グラフト材料の流動可能な性質は、この材料を髄膜の弯曲に十分に適合させることができる。加えて、流動可能なグラフト材料は、優れた封鎖を提供し、グラフト材料と髄膜との間の間隙の発生を有利に効率的に防止する。硬膜グラフトとしてのこの材料のさらなる利点は、流体不透過性の性質、および縫合なしの方法で植え込まれることができることを含む。 One use of flowable collagen grafts is as a dural graft material to repair or protect damaged meninges in surgical procedures. The graft material can be implanted by applying an effective amount of flowable collagen graft through the cranial opening by a desired application technique (eg, by ejection from a delivery device), and in the relevant area the meninges It is provided in the state which contacted. An effective amount of flowable collagen dural graft material may include an amount sufficient to slightly overlap and contact a portion of the intact meninges. The flowable nature of the graft material allows it to be well adapted to the meningeal curvature. In addition, the flowable graft material provides an excellent seal and advantageously and efficiently prevents the creation of a gap between the graft material and the meninges. Further advantages of this material as a dural graft include its fluid impermeable nature and that it can be implanted in a sutureless manner.
〔実施例〕
本発明に従う流動可能な硬膜グラフト材料の調製を説明する非限定的な実施例が、以下に提供される。ウシ由来コラーゲン(タイプI腱シート(Type I Tendon sheet))を、100〜500ミクロンの平均粒径を有する粉末になるよう粉砕する。その後、コラーゲン粉末を下記の4通りの比率で生理食塩水に加え、従来の60mLシリンジで、硬膜損傷の部位にこの材料を提供する際の重量パーセントの下限を決定する。
(A)25%(wt/wt%)コラーゲン粉末(2.0mLの生理食塩水に対して0.511gのウシ由来コラーゲン粉末)
(B)20%(wt/wt%)コラーゲン粉末(2.5mLの生理食塩水に対して0.511gのウシ由来コラーゲン粉末)
(C)11%(wt/wt%)コラーゲン粉末(4.5mLの生理食塩水に対して0.511gのウシ由来コラーゲン粉末)
(D)6%(wt/wt%)コラーゲン粉末(8.5mLの生理食塩水に対して0.511gのウシ由来コラーゲン粉末)
サンプル(A)から得られた製品は、濃厚なペーストであり、従来の60mLシリンジからの噴出には濃厚過ぎて適しておらず、鋳造可能ではない。サンプル(B)から得られた製品は、鋳造可能な、球状になった濃厚なペースト(balled thick paste)であり、同じく、従来の60mLシリンジから噴出可能ではない。しかしながら、この材料は、その他の適用技術により、例えば、より大きな開口を備えた特注のシリンジを用いるか、丸太形状(log shape)でこの材料を送達した後で欠陥部上に広げるか、またはコーキングガンのような機械的な利点を備えた送達装置を使用することにより、硬膜損傷の部位に適用されてもよい。サンプル(C)から得られた製品は、粘着性ではなく、いくらかの追加の生理食塩水をこの材料に加えても「洗い流される」ことなく(resists “wash away”)、鋳造可能でもあり、従来の60mLシリンジから噴出可能でもある。サンプル(D)から得られた製品もまた、鋳造可能で、従来の60mLシリンジから噴出可能である。
〔Example〕
Non-limiting examples illustrating the preparation of flowable dural graft materials according to the present invention are provided below. Bovine collagen (Type I Tendon sheet) is ground to a powder having an average particle size of 100-500 microns. The collagen powder is then added to the saline in the following four ratios, and a lower limit of weight percent in providing this material at the site of dural injury is determined with a conventional 60 mL syringe.
(A) 25% (wt / wt%) collagen powder (0.511 g of bovine-derived collagen powder with respect to 2.0 mL of physiological saline)
(B) 20% (wt / wt%) collagen powder (0.511 g of bovine-derived collagen powder with respect to 2.5 mL of physiological saline)
(C) 11% (wt / wt%) collagen powder (0.511 g of bovine-derived collagen powder with respect to 4.5 mL of physiological saline)
(D) 6% (wt / wt%) collagen powder (0.511 g of bovine-derived collagen powder with respect to 8.5 mL of physiological saline)
The product obtained from sample (A) is a thick paste, too thick to be suitable for ejection from a conventional 60 mL syringe, and is not castable. The product obtained from sample (B) is a castable, balled thick paste and is likewise not ejectable from a conventional 60 mL syringe. However, this material can be spread by other application techniques, for example using a custom syringe with a larger opening, spreading over the defect after delivering this material in a log shape, or caulking. It may be applied to the site of dural injury by using a delivery device with mechanical advantages such as a gun. The product obtained from sample (C) is not sticky, and even if some additional saline is added to this material, it is not “washed away” (resists “wash away”) and can be cast, It can also be ejected from a 60 mL syringe. The product obtained from sample (D) can also be cast and ejected from a conventional 60 mL syringe.
当業者は、上述の実施形態に基づいたさらなる特徴および利点を認識するであろう。したがって、本開示は、添付の請求項により示されていることを除いては、詳しく示され、記述されてきたことにより限定されるものではない。本明細書中で引用された全ての出版物および参考文献は、それら全体が参照により本明細書中に明白に組み込まれる。 Those skilled in the art will appreciate further features and advantages based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
Claims (16)
コラーゲン粉末と、
流動可能な粘稠度を与えるのに有効な量の液体と、
を含み、
前記材料は、硬膜グラフトとして有効である、グラフト材料。 In the graft material,
Collagen powder,
An amount of liquid effective to provide a flowable consistency;
Including
The material is a graft material that is effective as a dural graft.
コラーゲンが、タイプ1ウシ由来コラーゲン、ブタ由来コラーゲン、ブタ小腸粘膜下組織、およびウシ胎児皮膚からなる群より選択される、グラフト材料。 The graft material according to claim 1,
A graft material wherein the collagen is selected from the group consisting of type 1 bovine derived collagen, porcine derived collagen, porcine small intestine submucosa, and fetal bovine skin.
前記コラーゲンは、約25%(wt/wt%)の量で存在する、グラフト材料。 The graft material according to claim 1,
The graft material, wherein the collagen is present in an amount of about 25% (wt / wt%).
前記グラフト材料は、シリンジから注入可能である、グラフト材料。 The graft material according to claim 1,
The graft material can be injected from a syringe.
前記グラフト材料は、流体不透過性である、グラフト材料。 The graft material according to claim 1,
The graft material is fluid impermeable.
前記コラーゲン粉末は、約.1〜10,000ミクロンの範囲内にある粒径を有する、グラフト材料。 The graft material according to claim 1,
The collagen powder is about. A graft material having a particle size in the range of 1 to 10,000 microns.
前記コラーゲン粉末は、約100〜400ミクロンの範囲内にある平均粒径を有する、グラフト材料。 The graft material according to claim 6,
The graft material, wherein the collagen powder has an average particle size in the range of about 100-400 microns.
コラーゲン粉末と液体とを含み、
前記コラーゲン粉末は、約20%(wt/wt%)の量で存在しており、
前記グラフト材料は、流動可能で、押し出し成形可能である、グラフト材料。 In the graft material,
Collagen powder and liquid,
The collagen powder is present in an amount of about 20% (wt / wt%),
The graft material is flowable and extrudable.
前記コラーゲン粉末は、約11%(wt/wt%)の量で存在する、グラフト材料。 The graft material according to claim 8, wherein
The graft material, wherein the collagen powder is present in an amount of about 11% (wt / wt%).
前記液体は、生理食塩水である、グラフト材料。 The graft material according to claim 8, wherein
The graft material, wherein the liquid is physiological saline.
前記グラフト材料は、硬膜グラフトとして使用するのに有効である、グラフト材料。 The graft material according to claim 8, wherein
The graft material is effective for use as a dural graft.
コラーゲンおよび液体の混合物を含む流動可能な硬膜グラフト材料を所望の部位に適用することと、
前記部位の弯曲に前記硬膜グラフト材料を適合させることと、
を含む、方法。 In a method for repairing a damaged dura mater,
Applying a flowable dural graft material comprising a mixture of collagen and liquid to the desired site;
Adapting the dural graft material to the curvature of the site;
Including a method.
前記コラーゲンは、約6%(wt/wt%)の量で存在する、方法。 The method of claim 12, wherein
The method wherein the collagen is present in an amount of about 6% (wt / wt%).
前記コラーゲン源は、約10〜1000ミクロンの範囲内にある粒径を有するコラーゲン粉末である、方法。 The method of claim 12, wherein
The method wherein the collagen source is a collagen powder having a particle size in the range of about 10 to 1000 microns.
前記流動可能なグラフト材料は、シリンジからの噴出により適用される、方法。 The method of claim 12, wherein
The method wherein the flowable graft material is applied by ejection from a syringe.
前記流動可能なグラフト材料は、人の手で適用される、方法。 The method of claim 12, wherein
The method wherein the flowable graft material is applied by hand.
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EP2111878B1 (en) | 2017-10-18 |
EP2111878A3 (en) | 2010-02-24 |
CA2663642C (en) | 2016-08-16 |
JP5931318B2 (en) | 2016-06-08 |
ES2647218T3 (en) | 2017-12-20 |
US20120015006A1 (en) | 2012-01-19 |
US20090269413A1 (en) | 2009-10-29 |
CA2663642A1 (en) | 2009-10-23 |
AU2009201541B2 (en) | 2014-12-04 |
AU2009201541A1 (en) | 2009-11-12 |
US8039591B2 (en) | 2011-10-18 |
EP2111878A2 (en) | 2009-10-28 |
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